Second medical use patents remain a cornerstone of value creation in the life sciences industry, but enforcement continues to be fragmented. This panel will compare recent decisions and enforcement strategies across the UK, UPC and key global jurisdictions.

• Examine the new UPC plausibility and infringement test and how it applies in practice?
• Review the significance of the first UPC decision at the Dusseldorf Local Division (2025).
- What does it mean for assessing knowledge, intent, and infringement risk?
• Discuss the comparison with the USA and the recent wave of Skinny Label litigation.
• Understand the landscape of prior disclosure (G1/23) and its impact on the patentability of second medical use patents, as well as formulations, crystal forms and polymorphs.

Cross-border litigation poses unique challenges and opportunities for the pharmaceutical and biotech industries. This panel will explore the complexities of managing patent litigation across multiple jurisdictions, strategies for harmonizing legal approaches, and the impact of international regulatory environments.

• Review the major cross-border case law and discuss the resulting IP effects from decisions such as: Tecfidera, Apixaban, Rivaroxaban, Glucose monitoring device cases, Paxlovid and Jardiance.
• Discuss common challenges faced in cross-border patent litigation, including jurisdictional issues, differing legal standards, and enforcement of judgments.
• Understand strategies for harmonising litigation approaches and minimising conflicting decisions.

Roundtable discussions are back! Led by an expert(s) within a jurisdiction, you can discover, question and gain solutions to your most pressing challenges in patent litigation strategy. Jurisdictions that will be covered include:

Netherlands
Understanding the Doctrine of Equivalents in the Netherlands

UK
The Use of the Arrow Declaration as a Patent Litigation Tool

France
Saisie Contrefaçon- a New Tool in the UPC Armoury

Germany
The Power of German National Courts in light of the UPC

Europe
EPO Board of Appeals Review and the Effect on Litigation Strategy

Europe
The Interaction Between the EPO, UPC and National Courts for a Comprehensive Patent Strategy Europe Clinical Trial Regulatory Changes and the Intersection with your IP Strategy

Global
Regulatory Exclusivity Protection Calculations

China
Understanding the New PTE in China

India
Case Law Review Across India

USA
Navigating AI in U.S. IP Litigation Lauren Baker, Partner, Barnes & Thornburg John Cox Partner, Barnes & Thornburg

USA
Hatch Waxman Litigation Review in the USA

UPC
The Long Arm Reach of the UPC

Latin America
Patent Litigation Case Law Review

This session provides an in-depth analysis of recent high-profile biologics and biosimilar patent disputes across Europe, the USA, and Asia, including landmark cases involving Xtandi, Soliris, and antibody exclusivity challenges. Attendees will explore how evolving case law, patent claim constructions, and regulatory developments are shaping exclusivity periods, enforcement strategies, and market entry pathways. The session will also address comparative litigation trends, strategic patent considerations, and the complexities of navigating both branded vs branded and biosimilar patent conflicts globally.

• Examine key European rulings on Xtandi and Soliris patents, including patent validity challenges and injunction decisions.
• Analyse evolving antibody patent standards post-G2/21, Amgen vs Sanofi, and their impact on inventive step and exclusivity in the US and Europe.
• Explore strategic insights on BPCIA litigation timing, branded vs branded biologics disputes, and regulatory pathways for biosimilar market entry.

This session will examine the impact of recent case law and forthcoming legislative reforms on Bolar exemptions and safe harbor provisions in the US and Europe. Experts will discuss how evolving legal frameworks affect patent enforcement strategies, particularly concerning timing for preliminary injunctions and defining “imminent infringement.” Key cases and jurisdictional nuances will be analysed to help patentees and generics understand the shifting landscape.

• Review recent US case law on the § 271(e)(1) research exemption and its enforcement implications.
• Analyse anticipated changes to the European Medicines Directive broadening the Bolar exemption and their effects on patent litigation.
• Discuss jurisdictional differences in preliminary injunction trigger points and the challenges posed by the UPC’s holistic approach to imminent infringement.

Gain firsthand insight into how judges across Europe are approaching pharmaceutical and biotech patent litigation in both national and UPC forums. This session offers a rare opportunity to hear from the bench on key trends, procedural developments, and how judicial thinking is evolving post-UPC launch. Attendees will come away with a deeper appreciation for the considerations shaping decisions in complex cross-border disputes.

The EPO’s decision in G2/21 was meant to bring clarity, but questions around plausibility standards remain unsettled. This panel will assess how national courts and the EPO are applying the doctrine and the implications for life sciences patents.

• Compare approaches to plausibility in the UK, Netherlands, and EPO post-G2/21.
• How are national courts diverging from or aligning with the EPO's reasoning?
• Explore how plausibility has been tested in key cases including Apixaban and Dapagliflozi.
• Understand the vulnerability of life sciences patents under current plausibility thresholds and discuss the risks of invalidation, and how should companies adapt?
• Discuss the comparative written description and enablement standards in the USA and the latest case law which may affect your global litigation strategy.

Second medical use patents remain a cornerstone of value creation in the life sciences industry, but enforcement continues to be fragmented. This panel will compare recent decisions and enforcement strategies across the UK, UPC and key global jurisdictions.

• Examine the new UPC plausibility and infringement test and how it applies in practice?
• Review the significance of the first UPC decision at the Dusseldorf Local Division (2025).
- What does it mean for assessing knowledge, intent, and infringement risk?
• Discuss the comparison with the USA and the recent wave of Skinny Label litigation.
• Understand the landscape of prior disclosure (G1/23) and its impact on the patentability of second medical use patents, as well as formulations, crystal forms and polymorphs.